Systemic Lupus Erythematosus (SLE), commonly referred to as Lupus, is the prototypic autoimmune disease characterized by immune dysregulation (e.g., autoantibody and immune complex formation, complement activation, lymphocyte hyperreactivity, and skewed cytokine production) and consequent inflammatory tissue injury. The clinical manifestations of Lupus are heterogeneous, ranging from subtle symptoms to fatal disease, and may involve literally any tissue and organ of the patient. Although Lupus primarily affects women of reproductive age, it is a disease of any age and gender. The onset of Lupus may be insidious with symptoms such as fever, joint pain, and fatigue, which are common in non-Lupus diseases. Lupus is also characterized by periodic aggravation (flares) and remission of the disease. Meanwhile, serious organ damage may occur and go unrecognized since the early stage of the disease.
Diagnosing Lupus remains a major clinical challenge. Although several blood tests are commonly used to aid physicians in making a diagnosis of Lupus, no single test is sufficiently sensitive and specific for determining whether a patient has Lupus. The typical patient with Lupus requires four different physicians over a period of five years to be diagnosed in an accurate manner.
The non-specific symptoms and blood tests may sometimes be overlooked or overemphasized, resulting in underdiagnosis or overdiagnosis. Underdiagnosis and delayed diagnosis undoubtedly may lead to increased morbidity and mortality of patients who actually have Lupus. Conversely, overdiagnosis of Lupus may result in unnecessary exposure to toxic medications, which can be costly and have significant side effects in patients who do not have Lupus. Therefore, a timely and precise diagnosis has significant impact on not only the physical wellbeing of patients but also on the economic well being of the health care system.
This document describes methods and systems that may help solve at least some of the problems described above, and that may provide additional benefits.
Background prior art includes the following:    U.S. Pat. No. 8,126,654, issued to J. M. Ahearn and S. M. Manzi.    U.S. Pat. No. 8,080,382, issued to J. M. Ahearn and S. M. Manzi.    U.S. Pat. No. 7,585,640, issued to J. M. Ahearn et al.    U.S. Pat. No. 7,390,631, issued to J. M. Ahearn and S. M. Manzi.    U.S. Patent Application Publication No. 2010/0233752, naming J. M Ahearn, E. L. Erickson, D. M. Hawkins, S. M. Manzi, and T. Mercolino as inventors.
The background art listed above was developed based upon studies of patients who exhibited four or more American College of Rheumatology classification criteria for Lupus.